The therapeutic efficacy of guided therapy for PCI after acute myocardial infarction: A meta-analysis

Objective: To systematically evaluate the effects of lead therapies on percutaneous coronary intervention (PCI) after acute myocardial infarction (AMI). Methods: A randomized controlled trial (RCT) in the CNKI, Wanfang, VIP, ProQuest, PubMed, Cochrane Library, Scopus, and Web of Science databases was searched until January 2023. Two researchers strictly screened and checked the included literature, extracted relevant data, and used the Cochrane Manual to assess the risk quality of the literature. Using RevMan 5.3 software, Meta-analysis of 4 main outcome measures [cardiac function-related indicators, 6-minute walking distance (6 MWT), quality of life (SF-36), Seattle angina pectoris scale (SAQ)], and 3 secondary outcome measures [adverse event incidence, death incidence, and readmission rate]. Results: 22 studies were finally included with 1754 subjects, but the overall quality of the included studies was not high. The results of the meta-analysis showed that, in the cardiac function-related indicators compared to controls, improved left ventricular ejection fraction (LVEF) index (MD = 1.42, 95%CI [−0.94, 3.79], P < .00001); however, compared with the Baduanjin group, Tai Chi ball + Baduanjin group and control group, there was no significant difference (P > .05); compared with the control group, the guidance therapy group improved the left ventricular end-diastolic volume (LVEDV) index (MD = −4.67, 95%CI [−6.8, −2.71], P < .00001). In comparison, the lead group improved the 6 MWT (MD = 69.44, 95%CI [30.12, 108.76], P < .00001); the SF-36 score (MD = 10.05, 95%CI [8.68, 11.42], P < .00001])and the SAQ score (MD = 6.2, 95%CI [3.97, 8.44], P < .00001). Among the secondary outcome measures, the incidence of adverse events was statistically significant (RR = 0.17, 95%CI [0.1, 0.32], P < .00001); statistically significant (RR = 0.29, 95%CI (0.1, 0.87), P < .00001); readmission (RR = 0.39, 95%CI [0.17, 0.87, 0.89], P < .00001). Conclusion: Based on the current study, combining conventional therapy/ exercise or using simple lead therapy after PCI can improve the treatment effect and improve the quality of life.


Introduction
Acute myocardial infarction is usually caused by blockage of heart vessels, myocardial ischemia, hypoxia and necrosis, myocardial damage, and cardiac dysfunction, [1,2] The clinical manifestations of acute myocardial infarction include dyspnea, persistent severe retrosternal pain, and chest pain, which seriously affect the quality of life of patients. [3]With the rapid development of society, people lifestyles and habits have changed, and life pressure is also gradually increasing.
Coupled with the accelerated aging of the population, the incidence of acute myocardial infarction in China is increasing year by year.Percutaneous coronary intervention (PCI) is still the preferred treatment option for acute myocardial infarction, which can effectively reduce the mortality rate of patients [4,5] In addition.Early postoperative rehabilitation and continuous secondary prevention are also key to improving patient outcomes.Exercise rehabilitation, an important component of cardiac rehabilitation, can significantly improve cardiac function and quality of life.Traditional Chinese medicine guidance therapy, such as Taijiquan and Baduanjin, is the physical exercise therapy combining "form," "qi" and "god."Adjusting the Yin and Yang of the human body plays the role of supporting healthy and dispelling evil [6][7] At the same time, it can also reduce the risk factors, improve disease safety, and improve the quality of life of patients. [8]The guiding treatment takes the body, interest and heart as the basic elements, pays attention to the combination of physical movement, breathing and psychological adjustment, and assists the internal adjustment of drugs, so that the body achieves the state of "Yin and Yang secret ." [9] At present, there are many guidance therapies are currently being used for rehabilitation treatment after PCI for acute myocardial infarction.However, there is a lack of evaluation of the impact of different guidance therapies on the efficacy and quality of life after PCI for acute myocardial infarction; therefore, the selection of appropriate guidance therapy has high research value and clinical significance for the improvement of PCI after acute myocardial infarction.This study used a meta-analysis method to evaluate the efficacy and quality of life of guided therapy for PCI for acute myocardial infarction in order to provide a clinical basis for lead therapy in clinical treatment and rehabilitation of PCI for acute myocardial infarction.

Data and methods
The search strategy was to search the full text databases of Chinese academic journals (CNKI), Wanfang database (Wanfang), VIP database (VIP), China Biomedical database  Na Wei [10] 2023 (30/30) Routine rehabilitation and nursing + Baduanjin Routine rehabilitation care 4 wk Readmission rate, incidence of major adverse cardiovascular events and post-care cardiac function indicators, ADL One patient was included in the observation group and the control group 6 GuoGuo Liu [11] 2023 (30/30) Yixin drink + badbrocade Daily activities 12 wk Balance index, fall risk index, cardiopulmonary function index, and quality of life Not described XueFei Liang [12] 2022 (24/24) Routine treatment + Baduanjin Conventional therapy 6 mo SF-36, integrated quality of survival scale for CHD Not described Jing Zhou [13] 2022 100 (50/50) Conventional treatment + Baduanjin + blood house blood soup Conventional treatment plus bedside activities 24 wk LVEF, NT-proBNP levels, and 6 MWT Not described Yu Cai [14]  GuoGuo Liu [15] 2021  [16] 2021  [20]  Zhang [23] 2018 Two patients showed slight arm weakness after exercise and no special treatment HaiYang Shi [24] 2023 Yu [25] 2021 (SinoMed), PubMed, Cochrane Library, Embase, Web of Science, and 8 Chinese and English databases.The search will be completed until January 2023, and the languages will be Chinese and English.The Chinese search terms were: "Baduanjin, Wuqinxi, 6-character formula, Tai Chi exercise, Tai Chi, Tai Chi ball, Yi jin Jing, Qigong, practice, guidance therapy" acute myocardial infarction "and" percutaneous coronary intervention "; The English search term is: "" Baduanjin," Wuqinxi, 6-character formula, Tai Chi exercise, Taijiquan, Taiji ball, Yi Jin Jing, Qigong method, practice method, guidance therapy "acute myocardial infarction" and "percutaneous coronary intervention" uses the joint retrieval method of subject words plus free words.Literature inclusion and exclusion criteria 2.2.1 inclusion criteria: Study type: randomized controlled trials (RCTs).Subjects who met the diagnostic criteria for acute myocardial infarction [Cai Yu] and underwent PCI surgery.Interventions: The control group adopted conventional therapy, conventional treatment, traditional medicine therapy, other rehabilitation therapy, routine exercise, and routine care; the guidance group adopted simple guidance therapy, or combined guidance therapy based on the control group, which included Baduanjin, Wuqinxi, 6-character formula, Tai Chi exercise, Taijiquan, Tai Chi ball, and Yi Jin Jing.If multiple group comparisons occurred in the collected literature, only the groups related to this study were selected for inclusion.Outcome measures:Primary outcome measures: cardiac function, 6MWT, SF-36, SAQ, and 3 secondary outcome measures: incidence of adverse events, incidence of death, and readmission.
Exclusion criteria repeatedly published, data errors; only added Baduanjin exercise intervention between the 2 groups; cases were CHF disease with other organic diseases; animal experiment, review, experience summary; could not find full text; experiment design without comparable baseline data between groups; plagiarism and other problems; and does not involve a selected outcome indicator.

Literature screening and inclusion
By reading the title and abstract, we screened the documents out of the above inclusion criteria, then read the full text, and the documents of all the documents were judged whether to be included in the paper, the opinions of the third-party researchers.

Data extraction
Data were extracted from the original article by 2 independent researchers.Disagreements were resolved by a third researcher.The inclusion criteria were as follows: author, year, sample size, intervention, course of treatment, main evaluation indicators, and adverse reactions.

Risk of bias assessment
The quality of each trial was independently assessed by 2 researchers according to the Cochrane Risk of Bias instrument.Each item was classified as high-, uncertain-, or low-risk.Any disagreements were resolved by a third independent researcher.

Statistical analysis
The Meta-analysis was performed using RevMan 5.4 software.For the included literature with insufficient information, we contacted the authors by email to the requested data as far as possible.For continuously calculated data (different WOMAC dimensions and VAS), mean difference (MD) and 95% confidence intervals (Cis) were calculated.The hazard ratio (RR) and 95% confidence interval (CI) were used as dichotomous results Mei Lu [27] 2022 96 (48/48) Routine treatment + Tai Chi exercise and badJin Conventional therapy 3 mo Cardiac function, exercise endurance, quality of life, and the incidence of adverse cardiovascular events Two patients were included in the test group and 9 patients were included in the control group Ming Li [28]

Not described
YinHe Cai [29] 2022 60 (30/30) Routine treatment + Baduanjin Conventional therapy 3 mo Heart structural and functional indicators, EQ-5D, and serum inflammatory factors Do not appear XueYing Han [30] 2023 118 (57/61) Conventional therapy + Taiji ball combined with badJin Conventional therapy 1 mo Ability of daily living activities and quality of life Not described Shuai Zong [31] 2022  Table 1 (Continued ) www.md-journal.com(response rates).According to the availability of data in this study, the subgroups of different intervention types were analyzed in the control group.I 2 Tests were used to measure the statistical heterogeneity when I 2 < 40% and P > .1;otherwise, the random effects model was used.Sensitivity analyses were performed based on the trial quality, sample size, intervention duration, intervention session duration, and intervention frequency.
A funnel plot was used to assess the potential publication bias.

Literature search results
A total of 578 articles were retrieved in the above Chinese and English databases, including 578 Chinese articles and 0 English articles.0studies in the clinical registry.The screen was conducted according to other inclusion exclusion criteria, and 22 [10- 31] were included, as shown in Figure 1.

Basic characteristics of the included studies
A total of 1 261 study subjects were included, Among these patients, 631 cases were included in the lead group, 630 cases in the control group; The sample size of a single study was from 40 to 300 cases; The control group included conventional therapy, conventional therapy + traditional Chinese medicine therapy, conventional therapy + other rehabilitation therapy, usual exercise, usual care, The lead group was TCM lead therapy, or combined lead therapy in the control group, Guiding therapy includes Baduanjin (13), Tai Chi (2), Tai Chi ball (1), Tai Chi sports combined with Baduanjin (1) and Tai Chi ball combined with Baduanjin (2); In 15 studies using cardiac function as an outcome measure, Eight studies with 6 MWT as an outcome measure, Seven studies with SF-36 as the outcome measure, There were 2 studies using ADL as the outcome measure.See Table 1.

Offset risk assessment
12 studies stated the allocation method in the random allocation, and the assessment was low risk, while the remaining trial assessment was unclear; none mentioned the allocation hidden assessment as unclear, the blind method still mentioned no assessment as unclear, 6 trials had shedding cases, and the integrity of the data was high risk; and selective reporting and other offset assessments were low risk.See Figure 2 for further details.
Due to the large heterogeneity of this index, sensitivity analysis is needed, and the original forest map showed that the publication bias of 5 articles [13,14,16,18,22] was large, and the heterogeneity was significantly reduced after elimination (P = .11and I 2 = 48%).A fixed-effects model can be used.The results still showed that the LVEF index of patients with improvement (MD = 4.16,95%CI [2.9, 5.42], P < .00001)had low sensitivity and relatively stable results.
Due to the large heterogeneity of this index, sensitivity analysis was needed, and the original forest map showed that the publication bias of 2 articles [23,27] was large, and the heterogeneity was significantly reduced after elimination (P = .79and I 2 = 0%).The fixed-effects model was used for analysis.
As Tai Chi only combined the effect sizes of the 3 studies, the deletion heterogeneity did not change significantly.The [25] course of Yu Dongmei was 4 months, the [24] course of Shi Haiyang [24] was 12 weeks, and the [18] course of Xia Fumei was 8 weeks.The difference in treatment course may be the source of heterogeneity.Only one study was included in the Taiji ball group; therefore, a heterogeneity test was not performed.A Meta-analysis using a random effects model for the included 17 studies showed that the lead group improved the patient LVEF index compared with the control group.[MD= 1.42, 95%CI (−0.94, 3.79), P < .00001],shown in Figures 3 and 4.
The group were heterogeneous (P = .01,I 2 = 77%).The meta-analysis using the random-effects model was statistically significant, indicating that the group improved the LVEF index.[MD ＝ −8.95, 95%C (−14.48,−3.43), P = .002].Due to the large heterogeneity of this index, sensitivity analysis is required, and the heterogeneity of the study excluding Li Ming [28] (P = .2,I = I 2 = 39%) can be analyzed by the fixed effect model, and the results still showed that lead therapy could improve the LVEDV level [MD = −11.94,95%CI (−18.41,−5.47), P = .0003].The results were unchanged, with low sensitivity and stability.Only one study was included in the Taiji ball group; therefore, a heterogeneity test was not performed.Meta-analysis using the random effects model showed that the lead group had an improved LVEDV index compared with the control group (MD = −4.67,95%CI [−6.8, −2.71], P < .00001).See Figures 5 and 6 for details.

6MWT.
Ten studies [13][14][15][16][18][19][20][21][24][25] reported 6 MWT results, including 6 in the Baduanjin group, 1 in the Tai Chi ball + Baduanjin group, and 3 in the Tai Chi group. Subgroup anayses were performed according to the different interventions.The Baduanjin group showed heterogeneity (P < .00001,I 2 = 99%).A meta-analysis was performed, and the difference between the 2 groups was statistically significant, indicating that the patients had a 6 MWT index.[MD ＝ 69.5, 95%C (22.37, 116.64),P = .004].Due to the large heterogeneity of this index, sensitivity analysis is required.Excluding 4 articles [13][14][15]21] significantly decreased heterogeneity (P = .45and I 2 = 0%), the fixed effect model can be used for analysis, and the results still showed that the lead therapy group could improve the 6 MWT level of patients.[MD= 100.36,95%CI (86.7114.1),P < .00001],unchanged results, low sensitivity, and relatively stable.For heterogeneity and the results showed heterogeneity (P < .00001,I 2 = 94%), the random effect models were statistically significant, indicating that the Taijiquan group improved patients with the 6 MWT index.As Tai Chi only combined the effect sizes of the 3 studies, the deletion heterogeneity did not change significantly.The [25] course of Yu Dongmei was 4 months, the [24] course of Shi Haiyang [24] was 12 weeks, and the [18] course of Xia Fumei was 8 weeks.The difference in treatment course may be the source of heterogeneity.Only one study was included in the Taiji ball + Baduanjin group; therefore, the heterogeneity test was not conducted.A Meta-analysis using a random effects model for the ten included studies showed that the lead group improved the patient 6 MWT index compared with the control group.[MD ＝ 69.44, 95%CI (30.12, 108.76),P < .00001]. See Figure 7 and 8 for details.
SF group: For the 5 included studies, the heterogeneity test showed homogeneity (P = .01,I 2 = 46%), and the lead group showed improved SF compared to the control group [MD = 7.83, 95%CI (5.52, 10.14), P < .00001].RE group: The 6 included studies showed good homogeneity (P = .19,I 2 = 33%), and the lead group showed improved RE compared with the control group, but the difference was statistically significant [MD = 7.84, 95%CI (5.51, 10.17), P < .00001].MH group: Five included studies passed the heterogeneity test and showed heterogeneity (P < .0001,I 2 = 83%), and the lead group showed improved MH compared with the control group (MD = 9.46, 95%CI [5.8, 13.12], P < .00001).Sensitivity analysis revealed that the heterogeneity decreased (P = .19,I 2 = 36%).Since the [16] course of the study lasted 2 months and the other study lasted [17] for 2 weeks, the difference in the course was considered as the source of heterogeneity.See Figures 9 and 10 for details.
Two [21,25] studies reported on the incidence of death.The heterogeneity test showed low heterogeneity among the studies (I 2 = 0%), and a fixed-effects model was used.Meta-analysis showed that the incidence of death decreased compared with that in the control group (RR = 0.29, 95%CI (0.1, 0.87), P < .00001).
3.4.6.Publication bias.For the LVEF with the largest number of included articles published bias, the funnel diagram shows left and right asymmetry; the literature is centered on the vertical line distributed on both sides, most of which is concentrated in the upper part of the funnel.Left and right symmetry is poor, and the results show that there may be publication bias, which may be related to low literature quality factors (Fig. 14).

Discussion
There are many kinds of traditional TCM guidance, high selectivity, easy to operate, and less limited by time and site, [35] Has obvious advantages over other modes of exercise.Currently, lead therapy is primarily used for the treatment of many diseases.Therefore, guidance therapy has a good research value for the clinical rehabilitation treatment effect after PCI for acute myocardial infarction.Indicators related to cardiac function are the most common objective indicators for evaluating the treatment effects of PCI after acute myocardial infarction.The SAQ scale is also an indicator of acute myocardial infarction.The SF-36 is an important indicator for evaluating the treatment of patients.Therefore, the above outcome indicators are of reference significance for evaluating the treatment effect and improving the quality of life after PCI for acute myocardial infarction.
The results showed that for the cardiac function-related indicators LVEF and LVEDV, the lead therapy and control groups significantly improved compared to the control group.For the 6 MWT index, the lead therapy group was also more effective than the control group.In the 8 dimensions of the SF-36, the lead treatment group scale score was higher than that of the control group, which improved the quality of life of the patients.However, the heterogeneity of these outcome indicators was high, and after sensitivity analysis, most of the causes of the heterogeneity were found.The SAQ scale and lead therapy group-related scores were also higher than those of the control group, with good homogeneity.Compared with the control group, the number and frequency of angina attacks were significantly reduced, maintaining a stable condition.The most obvious is that for the incidence of adverse events, fatality rate, and readmission rate, the incidence in the lead therapy group was lower than that in the control group, indicating that the safety, treatment effect, and stability of lead therapy have advantages compared with the control group.The advantage of lead therapy for patients after acute myocardial infarction PCI: Regular exercise of lead therapy will improve myocardial capillary density and blood perfusion, thus improving the contraction and relaxation ability of the heart, reducing myocardial ischemia, and improving the function of the vascular endothelium. [37]Most Baduanjin and Taijiquan are medium-and low-intensity aerobic exercises.Whole body movements improve cardiopulmonary function, increase body endurance, exercise ability, balance of the body, and the patient ability to perform daily activities. [38,39]Guiding therapy is a traditional work technique in ChinaStimulate Yang qi, the whole set of movements soft and slow, round live coherence, elastic combination, through the limb movement of the patient to warm heart Yang, relieve asthma, edema and other heart Yang symptoms, to achieve the purpose of improving the heart.At the same time, the movement emphasizes "interest adjustment."[42] To improve the quality of life, and because of its high safety, not limited by the site equipment, low economic cost, and higher natural patient compliance, it can be vigorously promoted in clinical practice.

Limitations and perspectives of this study
The number of lead therapies included in this study is relatively small, including 13 Ba Duan Jin, 2 Tai Chi, 1 Tai Chi ball, 1 Tai Chi movement and 2 Tai Chi Jin; which may bias the research results.All documents were Chinese, and the research subjects were Chinese, which may have resulted in publication bias.The number of included documents was relatively small, including 8 badJin, 4 Taijiquan, 1 Shu Xin Yang Qigong, 1 Shaolin internal power, and 1 Yixin Cao.It is suggested that more high-quality research be conducted in the future.The interventions have not been standardized, and there is no unified standard for the intervention course, protocol, cycle, frequency, method, time, and intensity in the lead therapy literature in the included studies, resulting in heterogeneity among the literature.An expert consensus should be formed in the field of lead therapy treatment for acute myocardial infarction after PCI, and standardized guidelines for lead therapy treatment should be formulated to provide guidance for clinical practice.Common quality of the literature, including only 2 mentioned the blind and allocation scheme, the rest of the literature are not mentioned, may lead to selective bias, suggest that in the future clinical research, should pay attention to the blind and allocation scheme, ensure the completeness of the report results data, and improve the quality of RCTs.

Figure 1 .
Figure 1.Results of the literature search.

Figure 3 .
Figure 3.The meta-analysis results of group LVEF comparisons.LVEF = left ventricular ejection fraction.

Figure 4 .
Figure 4.The meta-analysis results of the 2-group LVEF comparisons after sensitivity analysis.LVEF = left ventricular ejection fraction.

Figure 6 .
Figure 6.The meta-analysis results of the 2-group LVEDV comparisons after sensitivity analysis.LVEDV = left ventricular end-diastolic volume.

Figure 10 .
Figure 10.The meta-analysis results of 2-group SF-36 comparisons after sensitivity analysis.SF-36 = quality of life.

Figure 11 .
Figure 11.The results of the meta-analysis of group SAQ comparisons.SAQ = Seattle angina pectoris scale.

Table 1
Presents their basic characteristics.